How clinical trials are monitored

Recruiting patients

Once you have been invited to take part in a trial and have asked and satisfied all your questions, you will be asked to give your consent. You can still say no. If the research involves children then a parent or guardian will have to give their permission for them to take part. You will be asked to sign a form to say you agree to take part and have understood what the trial involves.

Monitoring trials

Most trials are monitored all the way through by a special committee set up for that purpose. The committee will receive regular reports from the researchers about how the trial is progressing, how many people have been recruited, how many people have left the study, what side effects there have been, any feedback from the patients involved and the results so far. Based on these reports the committee may recommend that the trial continue for longer, continue as it is, continue but with some changes or, if they think the trial may be causing harm to patients, that it is stopped early. The researchers also have to communicate with the ethics committee if there are any unexpected results or side effects that may put patients at harm. The ethics committee has the power to stop the trial or recommend changes to the protocol.

Leaving a trial

If you decide that your condition is getting worse during the trial or that the treatment you are receiving on the trial is not helping you then you have the right to leave the study. You can chose to leave at any point and you don’t have to give a reason.